Application
Sinus Implant Deployment System
Challenge
Biocompatible lubricants are often recommended for medical applications, especially those that may come in contact with the skin or body cavity. These lubricants should not be confused with food-grade lubricants which are not required to pass ISO-standard biocompatibility testing. A customer designing a hand-held, sinus implant deployment system approached us in search of a lubricant for their silicone O-ring. The customer was only able to find silicone-based lubricants on the market, which are not compatible with silicone components. They came to us in search of a non-silicone, biocompatible lubricant to seal their O-ring and protect the implant against saline and water. They also needed a lubricant that was compatible with E-beam sterilization
Solution
NYEMED 7471
A completely fluorinated, inert fluid, exhibiting low solubility
- Biocompatible per ISO 10993-5, 10993-10, and 10993-11
- Does not swell plastics and elastomers
- Seals against moisture
- Resists oxidation and chemicals
Results
We sent the customer two lubricants from our biocompatible NYEMED product line for testing. Ultimately, NYEMED 7471 passed the customers material compatibility and e-beam sterilization testing. The product was also able to successfully seal the O-ring to prevent saline from reaching the implant. The customer’s application is now FDA-approved and NYEMED 7471 has been approved for its delivery system.
Advantages
- Biocompatible
- Does not swell plastics and elastomers
- Resists oxidation and chemicals
